Prospective Multi-center Study to Evaluate the Safety and Effectiveness of the OR3O Dual Mobility System in Primary and Revision Total Hip Arthroplasty (THA) Procedures

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Hip Arthroplasty
  • Age: Between 18 - 75 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Participant is a suitable candidate for implanting the OR3O™ Dual Mobility System in primary or revision total hip replacement in the Investigator’s judgement.
    2. Participants are skeletally mature in the Investigator’s judgement
    3. Participants have any of the following conditions:
      • Advanced degeneration of the hip joint as a result of degenerative, posttraumatic, or rheumatoid arthritis (RA)
      • Fracture or avascular necrosis of the femoral head
      • Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement
      • All forms of osteoarthritis (OA)
      • At risk of hip dislocation
      • Femoral neck fracture or proximal hip joint fracture
    4. Those who can provide written informed consent and willing and able to participate in the required follow up visits and complete study activities.

You may not be eligible for this study if the following are true:

    1. Subject has conditions that would eliminate or tend to eliminate adequate implant support or prevent the use of an appropriately-sized implant
    2. Subjects have dysplasia of hip joint with CROWE Grade III, IV.
    3. Has bodily disease(s) that may interfere with THA survival or outcome
    4. Subjects with life expectancy of less than 10 years.
    5. Mental or neurological conditions which impair the subject’s ability or willingness to restrict activities.
    6. Has physical conditions or activities which tend to place extreme loads on implants
    7. Subjects with neuromuscular dysfunctions which will cause unstable hip joint or abnormal gait after surgery.
    8. Emotional or neurological condition that would pre-empt their ability or willingness to participate in the study.
    9. Subjects with an active infection – systemic or at the site of intended surgery.
    10. Has a Body Mass Index > 40.0 kg/m².
    11. Subjects with known allergy to any component of the devices used in the study.
    12. Pregnant or breast feeding female subjects
    13. Those who entered in another investigational drug, biologic, or device study within 30 days of active study participation.



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